Name:
AquaVit D3 Release form Drops. MNNcholecalciferol. Composition 1 ml of solution contains: active substance: cholecalciferol (vitamin D3) – 15000 IU; excipients: macroglycerol ricinoleate, citric acid monohydrate, sucrose, disodium hydrogen phosphate dodecahydrate, benzyl alcohol, anise flavor (anise oil, ajgon oil, benzyl alcohol, propylene glycol), purified water.
Description:
Colorless to yellowish opalescent liquid with an aniseed odour. Pharmacotherapeutic group Vitamin D and analogues. Cholecalciferol. ATC code: A11CC05. Pharmacodynamic properties Mechanism of action Vitamin D regulates the balance of calcium and phosphate. Cholecalciferol and, to an even greater extent, its hydroxylation products cause the formation of calcium transport protein in the small intestine mucosa. This leads to increased absorption of calcium and phosphate from the intestines. In the kidneys, vitamin D stimulates the reabsorption of calcium and phosphate. Vitamin D deficiency leads to rickets in the growing body and osteomalacia in adults. The so-called vitamin D3 is considered to be a precursor of the steroid hormone according to its production, physiological regulation and mechanism of action. In addition to physiological production in the skin, cholecalciferol can be supplied with food or as a drug. Inhibition of skin synthesis of vitamin D by exogenous cholecalciferol cannot prevent the risk of possible overdose and intoxication. Pharmacokinetic properties Absorption Vitamin D is readily absorbed from the gastrointestinal tract in the presence of bile. In case of reduced fat absorption, vitamin D absorption is also reduced. Distribution Vitamin D can be stored in adipose and muscle tissue for a long time. The effect of taking cholecalciferol appears slowly and lasts a long time. Biotransformation The active form of vitamin D3 is 1,25-dihydroxycholecalciferol, which is formed by hydroxylation of cholecalciferol in the liver and kidneys. Excretion Vitamin D and its metabolites are excreted primarily in the bile and faeces. Small amounts appear in the urine. Therapeutic indications – prevention and treatment of vitamin D deficiency; – treatment of rickets; – as an adjunct to the specific therapy of osteoporosis in patients at risk of vitamin D deficiency. Posology and method of administration Posology The individual dose is determined by the attending physician. The following dosing rules generally apply: Vitamin D deficiency prevention Tolerable Upper Intake Level** IU/day Drops/day IU/day 0-6 months* 400-800 1-2 1000 6-12 months* 400-800 1-2 1500 1-3 years* 400-800 1-2 2500 4-8 years 600-1000 2 3000 9-18 years 600-1000 2 4000 19-70 years 600-1500 2-3 4000 Over 70 years 800-1500 2- 3 ‘ 4000 The following schedule is a guideline for the prevention of vitamin D deficiency (prophylaxis is usually given from the second week of life, from the first year of life and during the period of weak sunlight for the next two years): Newborns and infants during the first year of life: from the second weeks of life: 1 drop per day (about 500 IU); the optimal recommended dose is 400 IU per day Premature infants during the first year of life: from the second week of life: 1-2 drops per day (about 800 IU) Children (1-3 years) at risk during the winter months (weak sunshine) light): 1-2 drops per day (about 800 IU). ** Increased risk of side effects if exceeded, so do not take without medical supervision Treatment of rickets The total amount of vitamin D needed depends on the severity of the disease. For existing rickets, treatment begins with 200,000 IU, followed by 1,000 to 5,000 IU daily (approximately 2 to 10 drops). For initial treatment, the use of dosage forms with a higher dosage is recommended. Rickets treatment IU/day Drops/day 0-6 months Individual therapy! Initial administration of 200,000 IU (“pulse therapy”), then 1000-5000 IU daily. For “pulse therapy” the use of dosage forms with a higher dosage is recommended. For initial treatment, the use of dosage forms with a higher dosage is recommended. Subsequently: 2-10. 6-12 months 1-3 years 4-8 years 9-18 years Vitamin D deficiency treatment Vitamin D deficiency treatment Tolerable Upper Intake* IU/day Drops/day IU/day 0-6 months First 6 weeks: 2000 Thereafter: 400 -1000 First 6 weeks: 4 Next: 1 -2 1000 6-12 months 1500 1-3 years First 6 weeks: 2000 Next: 600-1000 First 6 weeks: 4 Next: 2 2500 4-8 years 3000 9-18 years 4000 19-70 years First 8 weeks: 6000 Next: 1500-2000 First 8 weeks: 12 Next: 3-4 4000 Over 70 years 4000 osteoporosis in patients at risk of vitamin D deficiency As an adjunct to specific therapy for osteoporosis in patients at risk of vitamin D deficiency Tolerable Upper Intake* IU/day Drops/day Drops/week IU/day Adults 800-1500 2-3 14-21 4000 *Increased risk of side effects if exceeded, so do not take without medical supervision b Application and dosage Orally. The drug is taken in a spoonful of clean drinking water. Compatibility with other liquids (juices, breast milk, etc.) has not been studied. 1 drop contains about 500 IU of vitamin D. In order to accurately measure the dose of the drug, you should hold the bottle at an angle of 45 ° while counting the drops. Contraindications – hypersensitivity to the active substance or any of the excipients listed in section 6.1; – medical conditions leading to hypercalcemia or hypercalciuria (patients with impaired excretion of calcium and phosphate from the kidneys, treatment with benzothiadiazine derivatives and immobilized patients); – calcium-containing nephroliths; – hypervitaminosis D; – severe atherosclerosis; – severe renal failure. Precautions The degree of vitamin D deficiency can be determined by measuring 25OHD (25-hydroxyvitamin D). In adults, serum 25OHD levels should not exceed 80 ng/mL. Values above 150 ng/mL represent a health-threatening overdose. During long-term treatment with vitamin D3, it is necessary to regularly monitor the level of calcium in serum and urine. If necessary, the dose should be adjusted according to the level of calcium in the blood serum. In case of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment discontinued. Kidney function should be monitored during long-term treatment by measuring serum creatinine. AquaVit D3 should be used with caution in patients with impaired renal function and effects on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be considered. In case of severe renal insufficiency, AquaVit D3 is not used. When indicated, other vitamin D preparations should be used. Cholecalciferol should be used with caution in patients with sarcoidosis (risk of increased metabolism of vitamin D to its active form) and in patients with osteoporosis during immobilization (increased risk of hypercalcemia). AquaVit D3 should be used with caution in patients receiving concomitant treatment with cardiac glycosides or thiazide diuretics (see Section 4.5). Additional doses of vitamin D should be taken under close medical supervision. In such cases, it is necessary to frequently monitor the level of serum calcium and excretion of calcium in the urine. Use in children Especially in children, the simultaneous use of other products containing vitamin D should be avoided. In case of doubt, the doctor decides on the additional use of food fortified with vitamins or baby food and medicines containing vitamin D. Information on excipients The drug contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicinal product. The medicinal product contains benzyl alcohol (15 mg/ml). The amount of benzyl alcohol in 1 drop is 0.5 mg. Benzyl alcohol can cause allergic reactions, is capable of cumulation, its long-term intake increases the risk of serious adverse reactions, including breathing problems (“gasping syndrome”) in newborns and children under 3 years of age, as well as the risk of metabolic acidosis in adult patients . Prescribing the drug AquaVit D3, oral drops 15,000 IU / ml, for children under 3 years of age is permissible only after assessing the benefit / risk ratio. Interaction with other drugs and other forms of interaction Effect of other drugs on cholecalciferol Inhibitors of CYP450 metabolic enzymes, such as rifampicin, carbamazepine, phenytoin, barbiturates (eg, phenobarbital, primidone) and glucocorticoids, may reduce the effectiveness of vitamin D due to increased inactivation. Concomitant use of these drugs may increase the need for vitamin D. Isoniazid may reduce the effectiveness of vitamin Ds due to inhibition of the metabolic activation of vitamin D. Drugs that cause fat absorption, such as orlistat and cholestyramine, may impair the absorption of vitamin D. Elevated levels parathyroid hormones may increase the metabolism of vitamin D and therefore increase the requirement for vitamin D. Concomitant treatment with cardiac glycosides may increase their toxicity due to hypercalcemia (risk of arrhythmias). Strict medical supervision and, if necessary, monitoring of ECG and serum calcium levels are necessary. The simultaneous use of thiazide-type diuretics increases the risk of hypercalcemia, since they reduce the excretion of calcium in the urine. In this case, serum calcium levels should be regularly monitored. Magnesium-containing drugs (eg, antacids) should not be used during therapy, as this may lead to hypermagnesemia. Effects of cholecalciferol on other medicinal products Vitamin D3 may increase intestinal absorption of aluminum. Fertility, pregnancy and lactationDaily dose up to 400 IU/day So far, no risks have been known at this dose. Long-term overdose of vitamin D during pregnancy should be avoided, as the resulting hypercalcemia can lead to physical and mental retardation, supravalvular aortic stenosis, and retinopathy in the child. A daily dose above 400 IU/day of AquaVit D3 should be used with caution during pregnancy and only if the expected benefits outweigh the potential risks. Vitamin D overdose during pregnancy should be avoided, as prolonged hypercalcemia can lead to physical and mental retardation, supravalvular aortic stenosis, and retinopathy in the child. Breastfeeding Vitamin D and its metabolites are excreted in breast milk. Overdose in infants caused by vitamin D intake has not been observed. This fact, however, should be taken into account if the child receives supplemental vitamin D. Fertility There are no data available for AquaVit D3. The drug contains benzyl alcohol (15 mg / ml) or 0.5 mg in 1 drop. Benzyl alcohol can cause allergic reactions, is capable of cumulation, its long-term intake increases the risk of serious adverse reactions, including the risk of metabolic acidosis in adult patients permissible only after assessing the benefit/risk ratio. Influence on the ability to drive a car and work with mechanisms AquaVit D3 has no or little effect on the ability to drive a car and work with mechanisms. Undesirable effects Cholecalciferol may cause the following undesirable effects, especially in case of overdose: The frequency of adverse reactions is unknown (cannot be estimated from the available data) – Metabolic and nutritional disorders: – Hypercalcemia, hypercalciuria – Gastrointestinal disorders: – Constipation, flatulence, nausea, abdominal pain, diarrhea. Reporting Suspected Adverse Reactions It is important to report suspected reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union. In the Republic of Belarus, it is recommended to report adverse reactions to the information database on adverse reactions (actions) to drugs, including reports of drug failure (UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, http:www.rceth. by). Overdose Overdose can lead to hypervitaminosis and hypercalcemia. Hypervitaminosis is expressed in uncharacteristic symptoms such as headache, loss of appetite, weakness, weight loss, gastrointestinal disorders (nausea, vomiting, constipation) and growth disorders. Persistent hypercalcemia can lead to polyuria, polydipsia, nausea, vomiting, constipation, muscle weakness, paresis, weakness, nocturia, proteinuria, anorexia, hypercholesterolemia, elevated transaminase levels, cardiac arrhythmia, hypertension, and radiographically detectable soft tissue calcification. The effect of vitamin D is reversed in severe overdose. The bones are decalcified, and calcium levels in the blood and urine are elevated. Calcification can occur in tissues, blood vessels, and kidneys. In addition, mental changes may occur, up to the development of psychosis. Treatment Treatment with vitamin D should be stopped immediately in case of overdose, dehydration that occurs in case of intoxication should be corrected. Other measures: diet low in calcium, administration of calcitonin, glucocorticoids. Storage conditions At a temperature not exceeding 25 ° C in a place protected from light. Do not refrigerate or freeze. Keep out of the reach of children. Shelf life 2 years. The opened vial must be used within 6 months. Do not use after the expiry date stated on the package. Conditions of release Release from pharmacies by prescription. Packing: 10 ml in a molded brown glass bottle, sealed with a stopper-dropper and a tamper-evident cap. 1 bottle with instructions is placed in a cardboard box. Buy AquaVit D3 drops 15000 IU/ml 10 ml №1
INN | CHOLECALCIFEROL |
---|---|
The code | 146 182 |
Barcode | 4 810 874 000 381 |
Active substance | cholecalciferol |
Manufacturer | Fortiva Med LLC, Belarus |
Reviews
There are no reviews yet.